LIOTHYRONINE SODIUM- liothyronine sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)

Available from:

Paddock Laboratories, LLC

INN (International Name):

Liothyronine Sodium

Composition:

liothyronine 5 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Thyroid hormone drugs are indicated: Liothyronine Sodium Tablets, USP can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef. Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

Product summary:

Rx Only Liothyronine Sodium Tablets, USP, 5 mcg, are white to off-white, round, flat, debossed "5" over "220" on one side and plain on the other in bottles of 100. Liothyronine Sodium Tablets, USP, 25 mcg, are white to off-white, round, flat, debossed "25" above the score and "222" below the score on one side and plain on the other in bottles of 100. Liothyronine Sodium Tablets, USP, 50 mcg, are white to off-white, round, flat, debossed "50" above the score and "223" below the score on one side and plain on the other in bottles of 100. 5 mcg 100's: NDC 0574-0220-01 25 mcg 100's: NDC 0574-0222-01 50 mcg 100's: NDC 0574-0223-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
PADDOCK LABORATORIES, LLC
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LIOTHYRONINE SODIUM TABLETS, USP
Drugs with thyroid hormone activity, alone or together with other
therapeutic agents, have been
used for the treatment of obesity. In euthyroid patients, doses within
the range of daily hormonal
requirements are ineffective for weight reduction. Larger doses may
produce serious or even
life-threatening manifestations of toxicity, particularly when given
in association with
sympathomimetic amines such as those used for their anorectic effects.
DESCRIPTION
Thyroid hormone drugs are natural or synthetic preparations containing
tetraiodothyronine (T ,
levothyroxine) sodium or triiodothyronine (T , liothyronine) sodium or
both. T and T are produced in
the human thyroid gland by the iodination and coupling of the amino
acid tyrosine. T contains four
iodine atoms and is formed by the coupling of two molecules of
diiodotyrosine (DIT). T contains three
atoms of iodine and is formed by the coupling of one molecule of DIT
with one molecule of
monoiodotyrosine (MIT). Both hormones are stored in the thyroid
colloid as thyroglobulin.
Thyroid hormone preparations belong to two categories: (1) natural
hormonal preparations derived from
animal thyroid, and (2) synthetic preparations. Natural preparations
include desiccated thyroid and
thyroglobulin. Desiccated thyroid is derived from domesticated animals
that are used for food by man
(either beef or hog thyroid), and thyroglobulin is derived from
thyroid glands of the hog. The United
States Pharmacopeia (USP) has standardized the total iodine content of
natural preparations. Thyroid
USP contains not less than (NLT) 0.17 percent and not more than (NMT)
0.23 percent iodine, and
thyroglobulin contains not less than (NLT) 0.7 percent of organically
bound iodine. Iodine content is
only an indirect indicator of true hormonal biologic activity.
Liothyronine Sodium Tablets, USP contain liothyronine
(L-triiodothyronine or LT ), a synthetic form of
a natural thyroid hormone